Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

A Phase IV, Open-Label, Multi-Centre Trial Evaluating the Conversion From Standard Phosphate Binder Therapy to Fosrenol® in Chronic Kidney Disease Stage 5 Patients on Haemodialysis

The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.

Study Overview

• Status: Terminated
• Conditions: Kidney Diseases
• Intervention / Treatment: Drug: Lanthanum carbonate

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Feldkirch Tisis, Austria, A-6807
    • Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
  • Linz, Austria, A-4010
    • Krankenhaus Elisabethinen/Dialysestation
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Zuid Oost Limburg
• Denmark
  • Fredericia, Denmark, 7000
    • Frederica Sygehus
  • Holbaek, Denmark, DK-4300
    • Holbaek Sykehus
  • Viborg, Denmark, 88 00
    • Sygehus Viborg
• Germany
  • Hamburg, Germany, 22297
    • Dialysezentrum Barmbek
  • Heilbronn, Germany, 74076
    • Dialysezentrum Heilbronn
  • Leipzig, Germany, 04178
    • Dialyse Leipzig
  • Lingen, Germany, 49808
    • Nephrologisches Zentrum Emsland
  • Oldenburg, Germany, 26127
    • nephrologische Schwerpunktpraxis
  • Villingen-Schwenningen, Germany, 78054
    • Diabetologische Schwerpunktpraxis
• Italy
  • Milan, Italy
    • University of Milan, San Paolo Hospital, Renal Division
• Netherlands
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Ziekenhuizen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
• Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
• Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).

Exclusion Criteria:

• Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
• Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
• Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
• Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: Lanthanum carbonate; 2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.; Other Names: FOSRENOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol	at Week 2 compared to baseline
Biochemical and haematological parameters	measured throughout the study
Assess safety & tolerability	Throughout the study

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2007
• Primary Completion (ACTUAL): December 10, 2007
• Study Completion (ACTUAL): December 10, 2007

Study Registration Dates

• First Submitted: March 23, 2007
• First Submitted That Met QC Criteria: March 26, 2007
• First Posted (ESTIMATE): March 27, 2007

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hyperphosphataemia
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SPD405-403; 2006-003364-64 (EUDRACT_NUMBER)